BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Pro-X1®

    Reg #: 3010368646 · FEI: 3010368646 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    X-BOLT ORTHOPEDICS
    Registration Number
    3010368646
    FEI Number
    3010368646
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 5 Northwood Court
    City
    Santry Dublin
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K221621

    Owner / Operator

    Firm Name
    X-Bolt Orthopedics
    Operator Number
    10085237
    Address
    20802 Unison Rd., Roundhill
    City
    Round Hill
    State
    VA
    Postal Code
    20141
    Country
    US
    Correspondent
    Brian Thornes

    US Agent

    Business Name
    MCRA
    Contact Name
    Hollace Rhodes
    Address
    803 7th Street, NW, 3rd Floor
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 5525807

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    Pro-X1®

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device